2021 Merit-Based Incentive Payment System (MIPS) Program: Self-Nomination User Guide for Qualified Clinical Data Registries (QCDRs) and Qualified ...
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2021 Merit-Based Incentive Payment System (MIPS) Program: Self-Nomination User Guide for Qualified Clinical Data Registries (QCDRs) and Qualified Registries June 2020
Table of Contents Introduction ...................................................................................................................................2 Purpose.....................................................................................................................................2 Background ...............................................................................................................................2 Accessing the QPP Portal.............................................................................................................4 Sign Up for a QPP Account ......................................................................................................4 Creating a Self-Nomination Form (prospective QCDRs/Qualified Registries) ............................10 Create a Self-Nomination........................................................................................................10 Tips .........................................................................................................................................12 Creating a Self-Nomination Form (existing QCDRs/Qualified Registries not in good standing) .13 Find your vendor name in the vendor list on the Vendor Landing page..................................13 Populating the 2021 Self-Nomination Form ............................................................................14 Vendor Contact Info Tab: ........................................................................................................16 Vendor Details Tab: ................................................................................................................22 Qualified Posting Details Tab..................................................................................................26 Attestations Tab ......................................................................................................................30 Populating the Improvement Activities Tab.............................................................................34 Populating the Promoting Interoperability Tab ........................................................................35 Populating the Individual MIPS Clinical Quality Measures Tab (QCDR/Qualified Registry) ...37 Populating the MIPS eCQMs Tab (QCDR/Qualified Registry)................................................40 Submitting the Data Validation Plan (QCDR/Qualified Registry) ................................................41 Populating the Data Validation Plan Tab ................................................................................42 Benchmarking Capabilities Tab (QCDR ONLY) .........................................................................45 QCDR Measures Tab (QCDR ONLY).........................................................................................46 Populating the 2021 Simplified Self-Nomination Form ...............................................................47 Submission of the Self-Nomination Form ...................................................................................49 Modifying a Self-Nomination .......................................................................................................51 Submitting QCDR Measures (QCDRs Only) ..............................................................................51 Completing the QCDR Measure Submission Template..........................................................51 QCDR Measure Permission Checklist ....................................................................................58 1
Withdrawing a Self-Nomination Form .........................................................................................59 Comments...................................................................................................................................60 How to View/Add Comment ....................................................................................................60 Resources...................................................................................................................................62 Help with Self-Nomination.......................................................................................................62 Help with QCDR Measure Development.................................................................................63 Introduction Purpose The 2021 Self-Nomination User Guide provides prospective Qualified Clinical Data Registries (QCDRs) and Qualified Registries with guidance on how to self-nominate for the 2021 performance period of the Merit-Based Incentive Payment System (MIPS) program. The intent of the guide is to provide vendors with step-by-step instructions on the data needed to populate, complete, and submit a completed Self-Nomination form for the Centers for Medicare & Medicaid Services (CMS) consideration. Background The Self-Nomination form is available through the CMS Quality Payment Program (QPP) portal (http://qpp.cms.gov/login), and should be accessed and completed by vendors seeking to participate in MIPS for the 2021 performance period as a QCDR and/or Qualified Registry. The QCDR and Qualified Registry Self-Nomination form contains the following tabs (please note, you are required to populate all required fields and tabs prior to submitting your Self- Nomination for CMS review): • Vendor Contact Info Tab – Vendors are required to enter their demographic and contact information. All fields marked with an asterisk (*) are required. • Vendor Details Tab – Vendors are required to enter their participation details. All fields marked with an asterisk (*) are required. • Qualified Posting Details Tab – Vendors are required to enter their cost information, services included in cost, last date to accept new clients, reporting information/supported, data collection methods, and performance categories. A Qualified Posting is developed for the approved QCDRs/Qualified Registries and include organization type, specialty, previous participation in MIPS (if applicable), program status (remedial action taken against the QCDR/Qualified Registry or terminated as a third part intermediary, if applicable), contact information, last date to accept new clients, virtual groups specialty parameters (if applicable), the approved measures, performance categories supported, 2
services offered, and costs incurred by clients. All approved QCDRs/Qualified Registries are included in the Qualified Posting that is posted on the CMS Quality Payment Program (QPP) Resource Library. All fields marked with an asterisk (*) are required. • Attestations Tab – Vendors are required to attest that they understand and are able to meet the requirements of participation for the 2021 MIPS performance period. • Improvement Activities Tab – Vendors are required to select the Improvement Activities supported for the 2021 MIPS performance period. Third party could be excepted from this requirement if ALL its MIPS eligible clinicians, groups or virtual groups fall under the reweighting policies. For the Promoting Interoperability, if the eligible clinician, group, or virtual group is using CEHRT; however, a third party intermediary may be excepted from this requirement if ALL its MIPS eligible clinicians, groups or virtual groups fall under the reweighting policies. Health IT vendors are required to submit data for at least one category. • Promoting Interoperability Tab – Vendors are required to select the Promoting Interoperability objectives and measures supported for the 2021 MIPS performance period. Third party could be excepted from this requirement if ALL its MIPS eligible clinicians, groups or virtual groups fall under the reweighting policies. For the Promoting Interoperability Performance Category, if the eligible clinician, group, or virtual group is using CEHRT; however, a third party intermediary may be excepted from this requirement if ALL its MIPS eligible clinicians, groups or virtual groups fall under the reweighting policies. Health IT vendors are required to submit data for at least one category. • MIPS Clinical Quality Measures Tab – Vendors are required to select the individual MIPS clinical quality measures (CQMs) supported for the 2021 MIPS performance period. QCDRs and Qualified Registries must support at least six quality measures, with at least one outcome measure. If an outcome measure is not available, at least one other high priority measure should be used. Please note some MIPS CQMs are also available as MIPS eCQMs. • MIPS eCQM Tab (optional) – Vendors may specify the Electronic Clinical Quality Measures (eCQMs) supported for the 2021 MIPS performance period. Please note some MIPS eCQMs are also available as MIPS CQMs. • Data Validation Plan Tab – Vendors are required to specify the methodology that they will use to validate the data submitted for the 2021 MIPS performance period. All fields marked with an asterisk (*) are required. Please refer to the 2021 QCDR Fact Sheet located in the QPP Resource Library for additional information on the QCDR participation requirements. The 2021 QCDR Fact Sheet is included in the 2021 Self-Nomination Toolkit. Please refer to the 2021 Qualified Registry Fact Sheet located in the QPP Resource Library for additional information on the Qualified Registry participation requirements. The 2021 Qualified Registry Fact Sheet is included in the 2021 Self-Nomination Toolkit. 3
The QCDR Self-Nomination form contains the following additional tabs (please note, you are required to populate all required fields and tabs prior to submitting your Self-Nomination for CMS review): • Benchmarking Capabilities Tab (optional) – Allows vendors to upload their benchmarking methodology. • QCDR Measures Tab (optional) – Allows QCDRs to upload QCDR measures and/or supplemental QCDR measure documentation for consideration for the 2021 performance period. You MUST utilize the 2021 QCDR Measure Submission Template to submit your QCDR measures. The 2021 QCDR Measure Submission Template is included in the 2021 Self-Nomination Toolkit located in the QPP Resource Library. Note: QCDRs who plan to submit QCDR measures for CMS consideration, must complete this tab utilizing the aforementioned template. To be considered for the 2021 MIPS performance period, prospective QCDRs and/or Qualified Registries will be required to submit their complete Self-Nomination form (inclusive of: MIPS Quality Measures, QCDR measures (QCDRs only), data validation plan) by 8:00 p.m. Eastern Time (ET) on September 1, 2020. Vendors who intend on participating in MIPS as a QCDR and Qualified Registry must complete and submit a Self-Nomination form for each vendor type for the 2021 MIPS performance period. CMS will only approve the organization for the vendor type identified within the self-nomination form. Applicants will not be able to update or submit their Self-Nomination after the deadline. CMS will not review late submissions. Failure to meet participation requirements and/or the falsification of any information provided during Self-Nomination, may result in remedial action being taken against the QCDR and/or Qualified Registry, or termination as a QCDR and/or Qualified Registry in the current and future program years of MIPS. CMS will post two Qualified Postings for the 2021 MIPS performance period, one for approved QCDRs and another for approved Qualified Registries. MIPS eligible clinicians, groups, and virtual groups may utilize the qualified postings to select a CMS-approved QCDR or Qualified Registry as their method of data submission for MIPS reporting. Additional resources regarding the 2021 MIPS performance period can be found on the QPP website at http://www.qpp.cms.gov/. Accessing the QPP Portal Sign Up for a QPP Account If you do not have a user account, you must create a user account. 1. Review the QPP Access User Guide (zip) that contains these files: 4
a. QPP Access at a Glance - Gives an overview of what you need to do to sign in to qpp.cms.gov and how you will manage access to organizations you want to access to self-nominate. b. Register for a HCQIS Access Roles and Profile (HARP) Account - Gives step-by- step instructions with screenshots for new users (those who have never signed into qpp.cms.gov) to create an account. c. Connect to an Organization - Gives step-by-step instructions with screenshots for any user to request authorization for an organization. Follow these steps if you need to self-nominate for an organization that is currently submitting on the QPP portal. This includes organizations that qualify for the simplified Self-Nomination form. You may need to connect to the organizations that you need to self- nominate. d. Security Officials: Manage Access - Gives step-by-step instructions with screenshots for a small group of users (those with a Security Official role) to approve requests to access their organization. Follow these steps if you need to self-nominate for an organization that is currently submitting on the QPP portal. This includes organizations that qualify for the simplified Self-Nomination form. You may need to request the Security Official role for the organizations that you need to self-nominate. 2. Navigate to the QPP portal. 3. Click on Register. 5
4. Click on “Register with HARP” to create your account. This process could take 5-15 minutes depending on how quickly your data is verified. HARP uses a third party service provided by Experian to verify your identity. This may require your social security number. Please select the “Security Official” role. 5. If you are self-nominating for a new vendor that is not currently active on the QPP portal, then you are done. 6
6. If you are self-nominating for an existing vendor that is active on the QPP portal, then you will need to connect to that organization and request the “Security Official” role. 7. Once you have created an account and logged in, you will land on the Manage Access page in the QPP portal and will see the “Registry/QCDR Self-Nomination” link to access the Self-Nomination form for QCDRs/Qualified Registries. You will see the organizations that you are connected to listed on the Manage Access page. If you are not seeing an existing vendor that is active on the QPP portal that you need to self-nominate, then you 7
will need to click on “Connect to an Organization” and connect to that organization and request the “Security Official” role. 8. Log in to the QPP portal. 9. Select “Sign In.” 10. Enter your User ID and Password and click the “Sign In” button. 8
Note: You must have the “Security Official” role assigned to complete and submit the Self- Nomination form for your organization(s). If you do not have the “Security Official” role, please submit a request to your organization’s “Security Official” via the QPP portal. If you are the “Security Official” for your organization, you may add this role to the appropriate staff via the QPP portal. Users can request access as a “Security Official” on the Manage Access page by clicking the “Connect to another Organization” link. You will be able to identify the QCDRs/Qualified Registries where the “Security Official” role has been approved as they are listed on the Manage Access page. The list of organizations that you can self-nominate will 9
match the list of organizations displayed on the Manage Access page under the Registry tab. If you know the organization that you need to self-nominate is active on the QPP portal and it is missing from this list, then you need to follow the steps above to “Connect to an Organization” in the “Security Official” role. Creating a Self-Nomination Form (prospective QCDRs/Qualified Registries) Create a Self-Nomination 1. Click “Registry/QCDR Self-Nomination” under Manage Access. 2. Click “ADD NEW VENDOR.” 10
3. Enter your vendor name (to be displayed on Qualified Posting) and indicate your prospective QCDR’s or Qualified Registry’s vendor type. Please ensure you have selected the correct vendor type, as this may affect your application. If you would like to self-nominate to become both a QCDR and Qualified Registry, you must complete an application for each vendor type. 4. Click “Save & Continue.” 11
5. Add ‘Watchers’ to monitor the status of your Self-Nomination form. This feature allows vendors to create a list of users who should receive email notification when comments are added. Tips Please consider the following tips as you prepare to self-nominate: • QCDRs and Qualified Registries must enter into and maintain a HIPAA compliant Business Associate Agreement with its participating MIPS eligible clinicians, groups or virtual groups that provides for receipt of patient-specific data. The Business Associate Agreement must account for the disclosure of Quality Measure results, numerator and denominator data, and/or patient-specific data on Medicare and non-Medicare patients on behalf of MIPS eligible clinicians, groups or virtual groups. 12
• All prospective QCDRs and Qualified Registries must submit their Self-Nomination form via the QPP portal. No other Self-Nomination form submission methods will be accepted. • Prepare the information needed to complete the Self-Nomination, measure information and Data Validation Plan in advance of the attempt to self-nominate via the QPP portal. Please note that the system will log you out after 30 minutes of inactivity. • A third party intermediary’s principle place of business and retention of associated CMS data must be within the U.S. Please Note: CMS policy prohibits non-U.S. citizens from accessing CMS IT systems. • The time required to complete this information collection is estimated to average ten hours per Self-Nomination, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the Self-Nomination form. • All fields marked with a red asterisk (*) are required. • Do not click “SUBMIT FOR REVIEW” until all the required fields of all tabs have been completed. You will not be able to successfully create a Self-Nomination unless all the required fields of all tabs have been filled out. Once created, you may go back and edit your submission until 8:00 p.m. ET on September 1, 2020. • Comment functionality is available in the Self-Nomination tool. It may be used for specifying any updates that have been applied to the Self-Nomination and/or informing CMS about any changes to the QCDR measures. Refer to “Modifying a Self-Nomination” section of this User Guide for additional information. • If you have questions about the 2021 QPP Self-Nomination Form, please contact the Quality Payment Program at QPP@cms.hhs.gov or toll free at 1-866-288-8292. Creating a Self-Nomination Form (existing QCDRs/Qualified Registries not in good standing) Find your vendor name in the vendor list on the Vendor Landing page If you are not seeing a vendor that you know is active on the QPP portal, then please refer to the Vendor Not Listed link for instructions on how to connect to that organization via the Manage Access page. 1. Click on “GET STARTED” button. 13
2. Add ‘Watchers’ to monitor the status of your Self-Nomination form. This feature allows vendors to create a list of users who should receive an email notification when comments are added. Populating the 2021 Self-Nomination Form 14
Disclaimer: A majority of the screenshots used in this User Guide were taken from the QCDR Self-Nomination form. Corresponding fields of the Qualified Registry Self-Nomination form may slightly differ. Please note that the “Populating the 2021 Self-Nomination Form” process should be completed by prospective QCDRs/Qualified Registries or existing QCDRs/Qualified Registries that currently are not in good standing (i.e., have remedial action taken against the vendor). Existing QCDRs/Qualified Registries in good standing may refer to the “Populating the 2021 Simplified Self-Nomination Form” section of the User Guide for information on self-nominating for the 2021 MIPS performance period. Existing QCDRs/Qualified Registries in good standing should contact the MIPS QCDR/Registry Support Team (PIMMS Team) at QCDRVendorSupport@gdit.com or RegistryVendorSupport@gdit.com if they cannot find or access the simplified self- nomination form instead of submitting a new self-nomination form. All changes in the form are automatically saved when you move to the next field. If you cannot complete the Self-Nomination form in one session, you may click the “Save & Close” button on the Self-Nomination form and come back to it later. All your changes will be saved. You may navigate between the Self-Nomination form tabs by clicking the appropriate tab on the left-hand side of the screen or at the bottom of the screen. 15
Vendor Contact Info Tab: 1. Enter the name of your prospective QCDR or Qualified Registry (if different from the vendor name) and your organization’s tax identification number (TIN). The QCDR or Qualified Registry name will be used as your QCDR or Qualified Registry name for CMS purposes. 16
Please provide if your organization will be participating as both vendor types (i.e., QCDR/Qualified Registry) for the 2021 MIPS performance period. The “Vendor Staff Access” field will ONLY be seen if the Self-Nomination form is for a new vendor. List QPP portal usernames for any additional staff at your organization who need to have access to the Self- Nomination form. To access an existing vendors Self-Nomination form, additional users must be connected to that organization as a “Security Official” role. 2. Enter the mailing address for your prospective QCDR or Qualified Registry. 17
3. Enter the prospective QCDR’s or Qualified Registry’s contact information. The “Phone Number” field should be populated as (XXX) XXX-XXXX. 4. Enter information for a program, clinical, and technical contact. Please note: You are required to provide three unique points of contact (POCs) for these three fields. Entering only one POC or different email addresses for the same POC (i.e., the same name is entered for program and clinical contact with two different email addresses) is not acceptable. If you would like to add additional POCs to be included in the email distribution to receive program announcements and support call information (if approved), please add the email address(es) in the “Additional Contacts” field. 18
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Note: Please provide one program, one clinical, and one technical POCs name, email address, and phone number. The information provided for each POC must be different and representative of at least three unique POCs. Listing the same individual as the program, clinical, and technical POC is not acceptable. This contact information will only be used in relation to your potential participation in the program. To ensure notices are received, please have these contacts add the Quality Payment Program to their safe/approved senders list. 21
Vendor Details Tab: 1. Click the Vendor Details tab. 2. Indicate your prospective QCDR’s or Qualified Registry’s vendor type. If “Health IT Vendor” or “Other” is selected, please specify. 3. Indicate if this is a new or existing QCDR or Qualified Registry that participated under MIPS and/or PQRS. Select all applicable years your prospective QCDR or Qualified Registry has participated in MIPS and/or PQRS as a QCDR or Qualified Registry. 4. Enter any other aliases or acronyms your prospective QCDR or Qualified Registry currently uses or has used for participation as a QCDR or Qualified Registry in previous program years. 22
5. Please indicate your prospective QCDR’s related clinical specialty (QCDRs only). 6. Does the prospective QCDR plan to submit QCDR measures? Please select Yes or No (QCDRs only). 7. Does the prospective QCDR plan to risk adjust the Quality Measures data that is integrated with the measure specifications? Please select Yes or No (QCDRs only). Upload your Risk Adjustment documentation in the “file uploads” section. Note: Do NOT upload the attachment in the comment section. 23
8. Describe how your prospective QCDR meets the definition of a QCDR. Please note that reiterating CMS’s definition of a QCDR does not suffice as justification as to how your prospective QCDR meets the definition. Please describe in detail your prospective QCDR’s clinical expertise and quality measure development experience, partnerships or collaborations, patient and/or disease tracking capability, method(s) used to foster quality improvement, and evidence of meeting the identified deficiencies to meet the definition of a QCDR (if applicable) (QCDRs Only). Please Note: the “Evidence of Meeting the Identified Deficiencies to Meet the Definition of a QCDR” only applies to existing QCDRs that received CMS feedback on not meeting the 2021 definition of a QCDR. Please refer to the 2021 QCDR Self-Nomination Fact Sheet for more detailed information on what is required. 24
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Qualified Posting Details Tab 1. Click the Qualified Posting Details tab. 2. Indicate the cost information as well as the type of services your prospective QCDR or Qualified Registry provides. If approved, this information will be included in the prospective 26
QCDR’s or Qualified Registry’s Qualified Posting. Please include frequency (monthly, annual, per submission) and if the cost is per provider/practice. Make sure to provide in detail the differences in cost/services if you are a vendor that is self-nominating as a QCDR and Qualified Registry. 3. Indicate the latest date your prospective QCDR or Qualified Registry can accept new clients. Please add the date as MM/DD/YYYY. The performance period starts on January 1, 2021 and ends December 31, 2021. 27
4. Indicate the data collection method(s) your prospective QCDR or Qualified Registry supports, select the performance category(ies) you will be supporting, and which reporting options you will support. If “Other” is selected, please specify the data collection method in the corresponding field. The Quality performance category is grayed out as your prospective QCDR or Qualified Registry must support Quality. Please Note: QCDRs and Qualified Registries are now REQUIRED to also support the Improvement Activities and Promoting Interoperability performance categories. A third party could be excepted from this requirement if ALL its MIPS eligible clinicians, groups or virtual groups fall under the reweighting policies. For the Promoting Interoperability, if the eligible clinician, group, or virtual group is using CEHRT; however, a third party intermediary may be excepted from this requirement if ALL its MIPS eligible clinicians, groups or virtual groups fall under the reweighting policies. Health IT vendors are required to submit data for at least one category. 28
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Attestations Tab 1. Click the Attestations tab. 2. Review the “Participation” statement and enter your name to attest that your prospective QCDR or Qualified Registry meets the participation requirements. In addition, please review and answer the Self-Nomination attestation questions and indicate if your prospective QCDR or Qualified Registry is able to meet these program requirements. To be considered, a prospective QCDR or Qualified Registry must attest “Yes” to all the Self-Nomination attestations. 30
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Please Note: These attestations include the acceptance of data exports directly from an EHR or other data sources. If you become aware that any submitted information is not true, accurate, and complete, you will correct such issues promptly prior to submission, or refrain from submitting it, and understand that the knowing omission, misrepresentation, or falsification of any submitted information may be punished by criminal, civil, or administrative penalties, including fines, civil damages, and/or imprisonment. Populating the Improvement Activities Tab 1. Click the Improvements Activities tab. 2. You may select “All”, “Some” or “None.” The list of supported Improvement Activities will appear if “Some” is selected. 3. You may select each Improvement Activity you will support from the list of all the Improvement Activities. Each individual activity selected will show after each Improvement Activity is selected. Select “All”, instead of selecting each Improvement Activity from the drop down if you will support all the Improvement Activities. 4. You may remove a selected Improvement Activity by clicking the “X” next to each selected Improvement Activity or click “Clear all” to remove all the selected Improvement Activities. In addition, you may use the “Search” function to look-up specific Improvement Activities. 5. To edit your Improvement Activities, refer to the “Modifying a Self-Nomination” section of this User Guide. 34
Populating the Promoting Interoperability Tab 1. Click the Promoting Interoperability tab. 35
2. You may select “All”, “Some” or “None.” The list of supported Promoting Interoperability objectives and measures will appear if “Some” is selected. 3. You may select each Promoting Interoperability you will support from the list all the Promoting Interoperability objectives and measures. Each individual objective or measure selected will show after each objective or measure is selected. Select “All”, instead of selecting each Promoting Interoperability objective and measure from the drop down if you will support all the Promoting Interoperability objectives and measures. 4. You may remove a selected objective or measure by clicking the “X” next to each selected objective or measure or click “Clear all” to remove all the selected objectives or measures. In addition, you may use the “Search” function to look-up specific objectives or measures. 5. To edit your objectives or measures, refer to the “Modifying a Self-Nomination” section of this User Guide. 36
Populating the Individual MIPS Clinical Quality Measures Tab (QCDR/Qualified Registry) 1. Click the MIPS Clinical Quality Measures tab. 37
2. You may select “All”, “Some” or “None.” The list of individual MIPS Clinical Quality Measures will appear if “Some” is selected. Please note that the MIPS Clinical Quality Measure must be used as specified. Measure specification changes are not permitted. 3. You may select from the list all the MIPS Clinical Quality Measures that you will support. Each MIPS Clinical Quality Measure selected will show after each measure is selected. Select “All”, instead of selecting each MIPS Clinical Quality Measure from the drop down if you will support all the MIPS Clinical Quality Measures. 4. You may remove a selected MIPS Clinical Quality Measure by clicking the “X” next to each selected measure or click “Clear all” to remove all the selected measures. In addition, you may use the “Search” function to look-up specific measures. 5. To edit your individual MIPS Clinical Quality Measures, refer to the “Modifying a Self- Nomination” section of this User Guide. 38
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Populating the MIPS eCQMs Tab (QCDR/Qualified Registry) 1. Click the MIPS-eCQM tab. 2. You may select “All”, “Some” or “None.” The list of individual MIPS eCQMs will appear if “Some” is selected. Please note that the MIPS eCQM must be used as specified. Measure specification changes are not permitted. 3. You may select from the list all the MIPS eCQMs that you will support. Each MIPS eCQM selected will show after each measure is selected. Select “All”, instead of selecting each MIPS eCQM from the drop down if you will support all the MIPS eCQMs. Please note that some of the MIPS Clinical Quality Measures have been e-specified. 4. You may remove a selected MIPS eCQM by clicking the “X” next to each selected measure or click “Clear all” to remove all of the selected measures. In addition, you may use the “Search” function to look-up specific measures. 40
Submitting the Data Validation Plan (QCDR/Qualified Registry) On this tab, you will be asked to specify the methodology your prospective QCDR or Qualified Registry will use for validating the data being submitted to CMS. All fields are required to be populated. The Data Validation Plan must be populated into the pre-formulated fields in the Self-Nomination form. CMS will only review the information populated in the pre- 41
formulated fields for purposes of satisfying the Data Validation Plan requirement. Please note, execution of your Data Validation Plan must be completed prior to the 2021 data submission period for all performance categories supported, so errors can be corrected prior to data submission for the 2021 performance period. All data that is eligible to be submitted for purposes of the MIPS program should be subject to validation, regardless of whether the clinician or group are MIPS eligible, voluntary, or are opting in. Populating the Data Validation Plan Tab 1. Describe how your prospective QCDR or Qualified Registry will verify MIPS eligibility for each clinician, group and/or virtual group (i.e., verify the clinician/group/virtual group meet the eligibility thresholds). Please note that clinician, group or virtual group self- attestation does not suffice. 42
2. Indicate the method your prospective QCDR or Qualified Registry will use to verify the accuracy of TINs and/or National Provider Identifiers (NPIs) intended for submission (i.e., NPPES, CMS Claims, tax documentation). Please Note: Clinician, group or virtual group self-attestation does not suffice. 3. Describe the method your prospective QCDR or Qualified Registry will use to accurately calculate reporting and performance rates (i.e., formulas included in the Quality Measure Specifications). 4. Describe the system your prospective QCDR or Qualified Registry will use to verify that only 2021 versions of Measures and Activities are reported for MIPS submission. 43
5. Describe the process used for completion of randomized audits of a subset of data prior to the submission to CMS. Periodic examinations may be completed to compare patient record data with submitted data and/or ensure the MIPS measures were accurately reported based on the appropriate measure specifications (that is, accuracy of numerator, denominator, and exclusion criteria). The QCDR/Qualified Registry must provide their sampling methodology that would be used to conduct the audits. The QCDR or Qualified Registry, at a minimum must meet the following sampling methodology to meet participation requirements: Sample 3% of the TIN-NPIs submitted to CMS, with a minimum of 10 TIN-NPIs or a maximum sample of 50 TIN-NPIs. At least 25% of the TIN- NPI’s patients (with a minimum sample of 5 patients or a maximum sample of 50 patients) should be reviewed for all measures applicable to the patient. Please Note: The Randomized Audit Plan and Detailed Audit Plan are not the same thing. See further details in Detailed Audit Plan for further information. 44
6. Describe the process used for completion of detailed audits if data inaccuracies are identified during the Randomized Audit. Please Note: The Detailed Audit Plan and Randomized Audit Plan are not the same thing. The Detailed Audit should include a description of the root cause analysis, how the error was corrected, and the percentage of your total clinicians impacted by the data error. Please note that the sample used for auditing in the Detailed Audit should be broadly selected and should not only include clinicians and groups impacted by the error in question. The aspect of the audit that is considered “the detail” is the specific error you are auditing for. Benchmarking Capabilities Tab (QCDR ONLY) This tab is optional and should ONLY be used by QCDRs if they are submitting QCDR Benchmarking Capabilities to CMS for consideration. 1. Indicate whether you have benchmarking capability (QCDR only). Upload your benchmarking documentation in the “file uploads” section. Note: Do NOT upload the attachment in the comment section. 45
QCDR Measures Tab (QCDR ONLY) This tab is optional and should ONLY be used by QCDRs if they are submitting QCDR Measures to CMS for consideration. 1. Indicate whether you will be using another QCDR’s measure(s) (QCDR only). If Yes is selected, please make sure to obtain documentation from the QCDR measure owner regarding permission to use their QCDR measure(s). Please note that verbal or inferred permission is not sufficient. CMS/The PIMMS Team will confirm that the appropriate permission has been given by the QCDR Measure owner as part of the QCDR Measure Review process. Upload your 2021 QCDR Measure Submission Template and supporting documentation in the “file uploads” section. Note: Do NOT upload the attachment in the comment section. 46
Populating the 2021 Simplified Self-Nomination Form Beginning with the 2019 MIPS performance period, a Simplified Self-Nomination process was introduced, to reduce the burden of Self-Nomination for those existing QCDRs/Qualified Registries that have previously participated in MIPS, in good standing (remedial action has not been taken against the vendor). A simplified Self-Nomination form is available only for existing QCDRs and Qualified Registries in good standing with no changes, minimal changes, and those with substantive changes as described below. Existing QCDRs/Qualified Registries in good standing should contact the MIPS QCDR/Registry Support Team (PIMMS Team) at QCDRVendorSupport@gdit.com and RegistryVendorSupport@gdit.com if they cannot find or access the simplified Self-Nomination form instead of submitting a new Self-Nomination form. 47
• QCDR/Qualified Registry in good standing with no changes – existing QCDRs/Qualified Registries in good standing may continue their participation in MIPS, by attesting that the QCDR’s/Qualified Registry’s previously approved: Data Validation Plan, services offered, cost associated with using the QCDR/Qualified Registry, measures, activities, and performance categories supported from the previous year’s MIPS performance period have no changes, and will be used for the upcoming performance period. Existing QCDRs/Qualified Registries (in good standing) may attest during the Self- Nomination period (July 1 - September 1), that they have no changes to their approved Self-Nomination application from the previous year of MIPS. • QCDR/Qualified Registry with minimal changes – existing QCDRs/Qualified Registries in good standing that would like to submit minimal changes to their previously approved Self-Nomination application from the previous year, may submit these changes and attest to no additional changes from their previously approved QCDR/Qualified Registry application, for CMS review and consideration during the Self-Nomination period (July 1 - September 1). Minimal changes may include but are not limited to; changes to the supported performance categories, adding or removing MIPS Quality Measures, adding or updating existing services offered and/or the cost associated with using the QCDR/Qualified Registry. • QCDR/Qualified Registry with substantive changes – existing QCDRs/Qualified Registries in good standing, may submit for CMS review and approval: substantive changes to QCDR measure specifications for existing QCDR measures that were approved in the previous year; submit new QCDR measures for CMS consideration without having to complete the entire Self-Nomination application process, which is required by a new QCDR. Substantive changes to existing QCDR measure specifications or any new QCDR measures would have to be re-submitted for CMS consideration by the close of the Self-Nomination period (8 p.m. ET September 1). Please note that all QCDR measures are reviewed on an annual basis. Additional examples of substantive changes may include (but are not limited to): updates to a QCDR’s/Qualified Registry’s Data Validation Plan or changes in the QCDR’s/Qualified Registry’s organization structure that would impact any aspect or designation of the QCDR/Qualified Registry status. You may begin your 2021 Simplified Self-Nomination form by clicking “GET STARTED” on the Self-Nomination landing page. Please note that prospective QCDRs and Qualified Registries that are eligible for the Simplified Self-Nomination form will see a Nomination Status of “Renewed.” 48
Please refer to the “Modifying a Self-Nomination” section of the User Guide for more details on populating the 2021 Simplified Self-Nomination form. Please Note: The new fields in the 2021 Self-Nomination form, fields that are now required or include validation for a specific format (i.e., telephone number), will need to be populated or updated for the Self-Nomination form to pass validation and be successfully submitted. 2020 Quality Payment Program performance year information will be available for public reporting on Physician Compare starting in late 2021. If you have any questions about this, please contact the Physician Compare support team at: PhysicianCompare@westat.com. Submission of the Self-Nomination Form 1. Once the required fields of all tabs are completed, the Self-Nomination status will update to “Draft Complete.” Please Note: You will not be able to successfully submit a Self- Nomination form unless all the required fields, marked with a red asterisk (*), of all tabs have been populated. 2. Once the form is filled out and all edits are finalized, you will need to click on the “SUBMIT FOR REVIEW” button to save the entire Self-Nomination form and complete the submission process. The “SUBMIT FOR REVIEW” button is located at the bottom of the left-side of the page under the Self-Nomination form tabs or on the Self-Nomination landing page. If necessary, use the “Edit” button on the Self-Nomination landing page to make changes to the Self-Nomination form after you have submitted it. If you have any 49
questions about the 2021 QPP Self-Nomination Form, please contact the Quality Payment Program at QPP@cms.hhs.gov or toll free at 1-866-288-8292. 3. You will receive a confirmation email with your Self-Nomination number. Please save the email for future reference. 4. It is suggested that you export a copy of your approved Self-Nomination form for your records. 5. Add ‘Watchers’ to monitor the status of your Self-Nomination form. This feature allows vendors to create a list of users who should receive email notification when comments are added. 50
Modifying a Self-Nomination To review or modify your Self-Nomination form, click “EDIT” on the Self-Nomination landing page. As a reminder, you will not be able to modify your submission after 8:00 p.m. ET on September 1, 2020. Submitting QCDR Measures (QCDRs Only) QCDR measures can be added to your QCDR Self-Nomination as an attachment. You are required to use the QCDR Measure Submission Template to self-nominate QCDR measures for the 2021 MIPS performance period. The QCDR Measure Submission Template should ONLY be filled out by QCDRs who meet the 2020 definition of a QCDR and wish to self-nominate QCDR measures for CMS consideration. Each QCDR may self-nominate a maximum of 30 QCDR measures for CMS consideration. Beginning with the 2021 MIPS performance period, QCDR measures may be approved for 2 years, at CMS discretion, by attaining approval status by meeting QCDR measure considerations and requirements. Upon annual review, CMS may revoke QCDR measure second year approval, if the QCDR measure is found to be: Topped out; duplicative of a more robust measure; reflects an outdated clinical guideline; requires QCDR measure harmonization; or if the QCDR that is nominating the QCDR measure is no longer in good standing. In instances where a QCDR believes a the low-reported QCDR measure that did not meet benchmarking thresholds is still important and relevant to a specialist’s practice, the QCDR may develop and submit a QCDR measure participation plan for our consideration. This QCDR measure participation plan must include the QCDR’s detailed plans and changes to encourage eligible clinicians and groups to submit data on the low-reported QCDR measure for purposes of the MIPS program. Completing the QCDR Measure Submission Template Enter all required data for each data field for each proposed QCDR measure. All columns denoted with an asterisk (*) are REQUIRED fields for each proposed QCDR measure. The template has built in validation to ensure that all REQUIRED fields are completed. The columns shaded in green denote fields that will be used by the MIPS QCDR/Registry Support Team 51
(PIMMS Team) and to communicate QCDR measure feedback, QCDR response, QCDR measure reconsideration meeting summary and final CMS measure decision, as applicable. Existing QCDRs (in good standing) will be provided a QCDR Measure Submission Template that includes their 2020 MIPS performance period approved/provisionally approved QCDR measure specifications. The pre-populated QCDR Measure Submission Template (for existing QCDRs in good standing only) will be uploaded to each existing QCDR’s respective 2021 Self-Nomination form in the QPP portal. Please note that the QCDR Measure Submission Template will need to be updated to include information for the new REQUIRED fields for measures already contained in the spreadsheet. In addition, any updates to previously approved/provisionally approved QCDR measure specifications from the 2020 MIPS performance period will need to be included in the QCDR Measure Submission Template for consideration. Furthermore, QCDRs in good standing may also submit new QCDR measures for CMS consideration for the 2021 MIPS performance period. Please ensure that the measure description and specifications are checked for grammar and typographical errors. In addition, the content entered for each proposed QCDR measure should appropriately reflect the column’s header. Complete all REQUIRED fields denoted with an asterisk (*). • Column A: PIMMS Tracking ID (PIMMS USE ONLY) – This is a unique ID that is used for PIMMS tracking purposes and internal use only. • Column B: Input Row Completeness – Provides the status of “Complete” or “Incomplete” for each row. “Incomplete” will display if all the REQUIRED fields have not been populated for a given entry. • Column C: Error Messages for Required Fields – Provides the user with an error message(s) regarding missing REQUIRED information for each entry. Also, missing REQUIRED information for each entry will have the cell highlighted in red after five REQUIRED fields have been populated in the template for the specific proposed measure. • Column D: Measure ID: Measure Title (Reference only) – This is a locked auto-filled cell that gives a reference point of Measure ID and Measure Title. • Column E: Measure Ready for PIMMS Review?* – Indicate if the given entry is "Ready for PIMMS Team Review", a "Work in Progress" or “Withdrawn.” Entries with a "Work in Progress" status will not be reviewed until the status is updated to "Ready for PIMMS Team Review.” • Column F: Do you own this measure?* – Enter "Yes", "No" or "Co-owned" for this field. By selecting "No" you are attesting that you do not own or co-own the measure and currently have the appropriate documentation (i.e., email, letter) giving your organization permission from the QCDR measure owner/steward to use the QCDR measure. Documentation to support permission will be verified. Please provide information in all unshaded columns. Please note that the QCDR who owns the measure must be an active and approved QCDR for the given Self-Nomination period. 52
• Column G: If you answered “No” or “Co-owned by 2 or more QCDRs”, please indicate the approved owner or co-owners – Provide the name of the active and approved QCDR(s) that own or co-own the QCDR measure. Example: XXX QCDR • Column H: Program Submission Status*: Select the measure submission status from the drop-down list that describes the measure submitted for review. (New or existing measure with/without changes). If you select ‘Existing Approved QCDR Measure With No Changes’, all cells that should not be changed will be shaded. Please ONLY update the cells that are unshaded. • Column I: If this is a previously CMS approved measure, please provide the CMS assigned measure ID* – Please enter the most recent CMS assigned QCDR measure ID if the QCDR measure was included in any MIPS performance period as an approved measure. Enter “N/A” if not applicable. Please do NOT self-assign a QCDR measure ID. CMS is responsible for assigning QCDR measure IDs. • Column J: If existing measure with changes, please indicate what has changed to the existing measure – Provide a detailed explanation of what changes were made to the measure. Example: Denominator exclusion added. • Column K: Can the measure be benchmarked against the previous performance period data? – Enter "Yes" or "No" to indicate if the benchmark from prior years is able to be used for comparison. • Column L: If applicable, please provide details why the previous benchmark cannot be used – Provide details regarding why the previous benchmark can or cannot be used in response to the changes to the existing measure. Example: The improvement addition to the numerator will make this measure an Outcome measure and, therefore, cannot be compared to the measure from last year. • Column M: Measure Title* – Provide the measure title, which should begin with a clinical condition of focus, followed by a brief description of action. Example: Preventive Care and Screening: Screening for Depression and Follow-Up Plan. • Column N: Measure Description* – Describe the measure in full detail. Example: Percentage of patients aged 12 years and older screened for depression on the date of the encounter using an age appropriate standardized depression screening tool AND if positive, a follow-up plan is documented on the date of the positive screen. • Column O: Denominator* – Describe the eligible patient population to be counted to meet the measures’ inclusion requirements. Example: All patients aged 12 years and older at the beginning of the measurement period with at least one eligible encounter during the measurement period. • Column P: Numerator* – The clinical action that meets the requirements of the measure. Example: Patients screened for depression on the date of the encounter using an age appropriate standardized tool AND, if positive, a follow-up plan is documented on the date of the positive screen. • Column Q: Denominator Exclusions* – An exclusion is anything that would remove the patient, procedure, or unit of measurement from the denominator. Enter “N/A” if not applicable. Example: Women who had a bilateral mastectomy or who have a history of a 53
bilateral mastectomy or for whom there is evidence of a right and a left unilateral mastectomy. • Column R: Denominator Exceptions* – Allow for the exercise of clinical judgement. Applied after the numerator calculation and only if the numerator conditions are not met. Enter “N/A” if not applicable. Example: Medical Reason(s): Patient is in an urgent or emergent situation where time is of the essence and to delay treatment would jeopardize the patient’s health status. OR Situations where the patient’s functional capacity or motivation to improve may impact the accuracy of results of standardized depression assessment tools. For example: certain court appointed cases or cases of delirium. • Column S: Numerator Exclusions* – An exclusion is anything that would remove the patient, procedure, or unit of measurement from the numerator, typically used in ratio or inverse proportional measures. Applied before the numerator calculation. Enter “N/A” if not applicable. Example: If the number of central line blood stream infections per 1,000 catheter days were to exclude infections with a specific bacterium, that bacterium would be listed as a numerator exclusion. • Column T: Primary Data Source Used for Abstraction* – Indicate the primary data source used for the measure. This may include but is not limited to administrative claims data, facility discharge data, chronic condition data warehouse (CCW), claims, CROWNWeb, EHR (enter relevant parts), Hybrid, IRF-PAI, LTCH CARE data set, National Healthcare Safety Network (NHSN), OASIS-C1, paper medical record, Prescription Drug Event Data Elements, PROMIS, record review, Registry (enter which Registry), Survey, Other (describe source). • Column U: If applicable, please enter additional information regarding the data source used – Provide additional information when "Registry" and/or "Other" is selected. You may list additional data sources used in addition to the primary data source. Example: ABC Registry. • Column V: NQF ID Number (if applicable) – Provide the assigned NQF ID number, if the submitted QCDR measure fully aligns with the NQF endorsed version of the measure. If no NQF ID number, enter 0000. Example: 0418. • Column W: High Priority Measure?* – Enter "Yes" or "No" to indicate if the measure is a high priority measure. • Column X: High Priority Type* – Indicate the high priority measure type. • Column Y: Measure Type* – Select which measure type applies to the measure. • Column Z: NQS Domain* – Select which NQS domain applies to the measure. • Column AA: Care Setting* – Select which care setting is included within the measure. If multiple care settings apply, select the option “Multiple Care Settings” and enter them in the next cell. • Column AB: If Multiple Care Settings selected, list Care Settings here – If “Multiple Care Settings” was selected, enter all Care Settings that apply. 54
• Column AC: Includes Telehealth?* – Please answer “Yes” or “No” if the QCDR measure’s denominator includes services provided via telehealth. (Please review the quality action to ensure that it is appropriate via telehealth). • Column AD: Which Meaningful Measure Area applies to this measure?* – Select ONLY one Meaningful Measure Area that best applies to the measure. • Column AE: Meaningful Measure Area Rationale* – Provide a rationale for the selected Meaningful Measure Area for the QCDR measure. Example: This measure identifies patients with depression and an appropriate follow-up treatment plan. • Column AF: Inverse Measure* – Indicate if the measure is an inverse measure. This is measure where a lower calculated performance rate for this type of measure would indicate better clinical care or control. The “Performance Not Met” numerator option for an inverse measure is the representation of the better clinical quality or control. Submitting that numerator option will produce a performance rate that trends closer to 0%, as quality increases. • Column AG: Proportional Measure* – Indicate if the measure is a proportional measure. This is a measure where the score is derived by dividing the number of cases that meet a criterion for quality (the numerator) by the number of eligible cases within a given time frame (the denominator). The numerator cases are a subset of the denominator cases (e.g., percentage of eligible women with a mammogram performed in the last year). • Column AH: Continuous Variable Measure* – Indicate if the measure is a continuous variable measure. This is a measure where a measure score in which each individual value for the measure can fall anywhere along a continuous scale and can be aggregated using a variety of methods such as the calculation of a mean or median (e.g., mean time to thrombolytics which aggregates the time in minutes from a case presenting with chest pain to the time of administration of thrombolytics). o CMS encourages QCDRs to construct the numerators to be proportional by establishing an expected benchmark based on guidelines or national performance data. Applying MIPS scoring methodology has proven to be challenging for non- proportional measures because variability in the data points makes decile creation based on a mathematical analysis very unpredictable. • Column AI: Ratio Measure* – Indicate if the measure is a ratio measure. This is a measure where a score that may have a value of zero or greater that is derived by dividing a count of one type of data by a count of another type of data. The key to the definition of a ratio is that the numerator is not in the denominator (e.g., the number of patients with central lines who develop infection divided by the number of central line days). Rates closer to 1 represent the expected outcome. • Column AJ: If Continuous Variable and/or Ratio is chosen, what is the range of the score(s)?) – Please provide a defined range of performance. If not a continuous variable and/or ratio measure enter “N/A.” Example: 0-250 minutes • Column AK: Number of performance rates to be calculated and submitted* – Indicate the number of performance rates submitted for the measure. If only one is calculated, enter '1.' 55
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